Medium-Term Plan "MTP2025" - Santen Pharmaceutical Co., Ltd. May 19, 2021
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Medium-Term Plan "MTP2025" Santen Pharmaceutical Co., Ltd. May 19, 2021 Copyright© 2021 Santen All rights reserved. 0
Presentation Shigeo Taniuchi Takeshi Ito Peter Sallstig Takayuki Yamada Representative Director of the Board, Corporate Officer, Corporate Officer, Director of the Board, Executive Corporate Officer, Head of Product Development Head of China Business President, Head of Japan Business, Division Chief Executive Officer Head of Japan Sales & Marketing Division Q&A Kazuo Koshiji Satoshi Suzuki Kenji Morishima Senior Corporate Officer, Senior Corporate Officer, Corporate Officer, Corporate Administration, Head of Corporate Development Division Head of China Product Development Chief Financial Officer(CFO), Department Head of Finance and Administration Division 1
Forward-Looking Statements Information given in this presentation contains certain forward-looking statements concerning forecasts, projections and plans whose realization is subject to risk and uncertainty from a variety of sources. Actual results may differ significantly from forecasts. Business performance and financial conditions are subject to the effects of medical regulatory changes made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates. The process of drug research and development from discovery to final approval and sales is long, complex and uncertain. Individual compounds are subject to a multitude of uncertainties, including the termination of clinical development at various stages and the non-approval of products after a regulatory filing has been submitted. Forecasts and projections concerning new products take into account assumptions concerning the development pipelines of other companies and any co-promotion agreements, existing or planned. The success or failure of such agreements could affect business performance and financial condition significantly. Business performance and financial conditions could be affected significantly by a substantial drop in sales of a major drug, either currently marketed or expected to be launched, due to termination of sales as a result of factors such as patent expiry and complications, product defects or unforeseen side effects. Santen also sells numerous products under sales and / or manufacturing license from other companies. Business performance could be affected significantly by changes in the terms and conditions of agreements and/or the non-renewal of agreements. Santen is reliant on specific companies for supplies of certain raw materials used in production. Business performance could be affected significantly by the suspension or termination of supplies of such raw materials if such an event were to adversely affect supply capabilities for related final products. Copyright© 2021 Santen All rights reserved. 2
1. Santen's Vision & Mid/Long-term Targets (KPI) 2. Business Plan & Strategy/Initiatives 3. Long-term Direction for Further Future Growth Agenda 4. Shareholder Return Policy 5. ESG Strategy/Initiatives 6. Details of Business Strategy Copyright© 2021 Santen All rights reserved. 3
1. Santen's Vision & Mid-/Long-term Targets (KPI) 2. Business Plan & Strategy/Initiatives 3. Long-term Direction for Further Future Growth Agenda 4. Shareholder Return Policy 5. ESG Strategy/Initiatives 6. Details of Business Strategy Copyright© 2021 Santen All rights reserved. 4
From Vision 2020 to Santen 2030 What we have achieved Challenges Achieving balance between strategic Vision 2020: Evolved into a investment and profitability "Specialized Pharmaceutical Profit margin/ROE declined despite growth Company with a Global Presence" Further clarification of financial discipline in investment decisions and value maximization of Rapidly expanded presence in each region by existing assets will be key capturing inorganic growth Improving the profit margin as well as organic growth While sales and profits increased, expenses for regional and business expansion depressed profit Established new organizational capabilities margins such as regulatory affairs, Necessary to optimize SG&A and COGS production and supply while entering and expanding sales in new countries Establishing a global organization Enhancing development and leadership capabilities is a work in progress Evolved into a global organization Achieving sustainable business growth and Drove growth by investing in R&D solving social issues and business development Proactive initiatives for DE&I and environmental protection Provided pharmaceutical solutions for Strengthening quality and quantity of external ophthalmic area disclosures Provide more concrete strategies/plans with numerical targets to address investor concerns Copyright© 2021 Santen All rights reserved. 5
CORE PRINCIPLE and WORLD VISION CORE PRINCIPLE “Exploring the secrets and mechanisms of nature in order to contribute to people’s health” * WORLD Happiness with Vision VISION The Happiest Life for every individual, through the Best Vision Experience * Santen’s original interpretation of a passage from the Zhongyong (The Doctrine of the Mean) by Confucius. Copyright© 2021 Santen All rights reserved. 6
Santen 2030 – Toward 2030 and beyond - Santen's VISION Become A Social Innovator Orchestrate and mobilize key technologies and players around the world, to deliver happiness through vision GOAL Aim to reduce the loss of social and economic opportunities for people around the world due to eye conditions A Ophthalmology Innovation in Ophthalmology and Acceleration of Ecosystem Development STRATEGY B Wellness Awareness and Proactive Care toward Better Eye Condition C Inclusion Building Society that is Inclusive regardless of Visual Impairment Copyright© 2021 Santen All rights reserved. 8
Evolution from Vision 2020 to Santen 2030 Santen 2030 (2021-2030) Vision 2020 (2011-2020) MTP2025 (2021-2025) Become a Social Innovator Expanded global market Transformation into a truly global presence ophthalmology Rx company Step 1 Step 2 Step 3 Expand overseas by leveraging Enhancing globalization and Leader in ophthalmology Japan's strengths entering new fields Santen as of 2011 Santen as of 2021 Core CN Business Cell/ US Cell/ Gene JP Asia Gene Core JP Out of Out of Businesses EMEA Asia Pocket Global Rx Pocket CN EMEA Digital (incl. US) Health Digital Expand globally as a top player in Health Ophthalmology prescription market Maximize the value of core businesses. from Japan. Established global Leverage to enter new businesses and presence (excl. US) new areas Achieve business consolidation in ophthalmic • Expanded presence in Asia and EMEA • Enter the US ophthalmic Rx market products, incl. US. after acquiring Merck products in 2014 through the platform of Eyevance Further evolve business model while expanding • Invest in future growth areas such as into new technology / out-of-pocket cell and gene therapy, out of pocket To become a Social Innovator that contributes market and digital health to society in the ophthalmic space Copyright© 2021 Santen All rights reserved. 9
Aiming for Growth in Adjacent New Areas by Leveraging Strengths Built up in Core Businesses Technology (Operation model) Digital / Device Small Molecules New Modality Rx Pharma Value Offering (Commercial model) PRESERFLO MicroShunt Core Treatment Businesses Cell (Reimburse US therapy Twenty Twenty Global Rx ment) Therapeutics (ex-US) Product (JV with Verily) expertise/ knowhow Treatment (out-of- Myopia Ptosis Santen's existing strengths pocket) (see next page) /Wellness Copyright© 2021 Santen All rights reserved. 10
Leveraging Santen’s Strengths for Further Expansion Track record of commercialization, monetization, and multi-region operations in ophthalmic area Organizational excellence Differentiation of product development through patient needs-driven innovation x repurposing Symbiotic business model specialized in ophthalmology that aims to continuously improve value of the patient experience together with ophthalmologists Customer Unparalleled customer equity in Japan, China and Asia equity Global network as a leading company in ophthalmic area (Pharmaceutical companies and startups, universities and research institutions, IT and other industries) Copyright© 2021 Santen All rights reserved. 11
Management Themes to be Addressed over Mid-/Long-term Santen 2030 (2021-2030) Vision 2020 (2011-2020) MTP2025 (2021-2025) Step3 Leader in ophthalmology Step2 Enhancing globalization and Step1 entering new areas Expand overseas by leveraging Japan's strengths A Strengthen global presence and profitability B Capture the potential of ophthalmic domain of core pharma business • Launch business in new areas • Determined shift in focus from "quantity" to – Establish US pharma business "quality" – Expand into areas such as cell/gene therapy, – Steadily monetize existing assets out-of-pocket and digital health • Enhancement of new pipeline + disciplined execution of LCM • Establish ophthalmology ecosystem – Regional expansion, indication – Promote cooperation and collaboration with expansion and LoE countermeasures other players mainly in China and Asia • Transformation into a "truly" global company – Global organization and process optimization – Investment in production facilities to establish global framework Copyright© 2021 Santen All rights reserved. 12
Positioning of Major Pipeline in MTP2025 (Step 2) Monetizing projects by leveraging Santen's development strengths (as a specialized ophthalmology pharmaceutical company) and enhancing development capability Launch - value maximization Promote steady development Early stage/in-licensing Glaucoma Glaucoma • STN1011700 (Eybelis) • STN1012600 (Sepetaprost) Multiple pipelines for • STN1013900 (Rhopressa) • STN1014000 (Rocklatan) future growth • STN2000100 (PRESERFLO MicroShunt) • Tapros new Instillation system product Myopia • STN1012700 (Atropine) (Glaucoma, dry eye, Dry eye • STN1013400 (AFDX) Major • STN1008903 (Diquas new formulation) BOTE, myopia, cell/gene pipeline Retinitis pigmentosa therapy, digital etc.) Allergy/inflammation • STN6000100 (jCell) • STN1007603 (Verkazia) • STN1011402 (Alesion new formulation) Thorough Life Cycle Management (Regional expansion, line extension, Ptosis LOE countermeasures) • STN1013800 (RVL-1201) Step2 Step3 (2026-2030) Timing of MTP2025 (2021-2025) revenue contribution Alesion Trademark of alliance partner Nippon Boehringer Ingelheim Copyright© 2021 Santen All rights reserved. 13
Concepts Behind Mid-/Long-term Targets Contribute to sustainable development of society by addressing social issues. Aim to increase corporate value over the medium- to long-term Contribution to society based on our corporate philosophy Management stance and mid-/long-term targets • Tenki ni sanyo suru Contribute to people with eye diseases and disorders and • Happiness with Vision healthcare professionals by providing products to meet needs Contribute to all stakeholders, including people suffering from eye diseases and disorders, healthcare Commitment to improve TSR as a comprehensive professionals and shareholders metric for enhancing shareholder value. In addition, commitment to balance ESG strength • Emphasize an appropriate balance between growth and profitability • Strengthen ESG: Set clear KPIs and enhance initiatives Copyright© 2021 Santen All rights reserved. 14
FY2025 targets and Image of Growth Toward Santen 2030 Achieve both sales growth and profit improvement to realize Top 1/2 TSR within the pharma industry, and provide stable shareholder returns Santen 2030 growth image FY2025 target Step 3 (~2030) Strengthen profitability of mid-/long- As of FY2020 Step 2 (~2025) term growth drivers. Improve global presence by integrating Step 1 (~2020) Strengthen core business profitability core businesses and new areas Global expansion of Launch mid-/long-term growth drivers core businesses TSR - Top 1/2 level in pharma industry Further improvement from FY2025 Net sales JPY249.6 B ≥ JPY315.0 B (CAGR 5%) ≥ JPY500.0 B Business Operating profit ratio 5.2%*1 (20.1%) ≥ 21% (≥ 24%) ≥ 30% Strategy (Core basis) Operating profit (IFRS) JPY12.9 B (JPY38.0 B ≥1.7times*4 vs. FY2020 (JPY66.0 B) ≥2.3 times vs. FY2025 (JPY150.0 B) adjusted for impairment loss*2) Financial Strategy ROE 2.2% ≥ 13% ≥ 20% Shareholder Dividend payout ratio Dividend payout ratio ≥ 40% Further enhance returns in line Shareholder return Value approx.30-50%*3+Buy-back +Opportunistic share buyback(s) with growth Business Overseas sales ratio 32% ≥ 50% ≥ 2/3 Targets New area sales ratio - - ≥ 30% *1 Impairment loss on STN2000100 depressed operating profit margin by 10.0%-points, *2 Operating profit adjusted for (added back) the impact of impairment losses, etc., described in *1, *3 164% in FY2020 due to the impairment loss described in *1, *4 Compared to operating profit adjusted for impairment loss Copyright© 2021 Santen All rights reserved. 15
1. Santen's Vision & Mid-/Long-term Targets (KPI) 2. Business Plan & Strategy/Initiatives 3. Long-term Direction for Further Future Growth Agenda 4. Shareholder Return Policy 5. ESG Strategy/Initiatives 6. Details of Business Strategy Copyright© 2021 Santen All rights reserved. 16
Business Plan Summary Demonstrate our ability to generate earnings through steady growth in core business and improved profitability. Target sales of JPY 315.0 B, core operating profit of JPY 75.0 B (24% margin) and operating profit of JPY 66.0B (21% margin) in FY2025 Core business New areas Total Core operating New disease profit/ratio Japan China Asia EMEA Americas /others (vs. FY2020) 315.0 JPY75.0 B 24% (+4%pt) Net Sales (JPY billions) 150.0 Operating profit/ratio (IFRS) (vs. FY2020) 40.0 50.0 35.0 24.0 16.0 JPY66.0 B 21% (+16%pt) CAGR -2% 11% 15% 6% 64% - 5% ('20-'25) In-house developed 2% products only*1 *1 Products for which Santen holds drug production and sales rights, Includes other revenue Copyright© 2021 Santen All rights reserved. 17
Key Strategies/Measures for Business Plan Achievement While expecting steady recurring profits in core businesses, will also launch and quickly monetize new areas for next-stage growth. In addition, will further strengthen foundation as a global company to support these businesses Key strategies/measures Company-wide financial KPIs A Profit ratio FY2020 FY2025 improvement in core 1 Profit maximization in each region JPY JPY315.0 B businesses Sales 249.6 B (CAGR +5%) B Establishment of revenue structure in 1 Americas Expansion of (Core) JPY75.0 B new areas Operating JPY50.1 B 2 New disease / other upsides (CAGR +8%) profit C 1 Strengthening capabilities of product development (Core) Strengthening Strengthening of product supply Operating 20% 24% of foundation 2 infrastructure profit ratio as a global company 3 Reflect strategies in company-wide financial KPIs and business KPIs 4 Establishing global platform Copyright© 2021 Santen All rights reserved. 18
A Products/Solutions Based on Needs of Patients in Japan While anticipating severe environment changes including LOE of existing products and NHI (National Healthcare Insurance) price revisions, aim to achieve a 2%-pt*1. improvement in contribution profit ratio in FY2025 through the introduction of products and solutions based on patient needs Target business structure in FY2025 Actions to achieve business plan Near-term environmental What we aim to be: Continuously launch of new products/formulations: changes: Promote product portfolio Plan to launch new, differentiated formulations by FY2025 Factors depressing existing product sales transformation through the launch of • Impact of NHI drug price revisions, new formulations LOE of certain existing products CAGR -2.0% 169.1 Alesion LX + Diquas Tapros with new 150.0 Alesion new formulation new formulation instillation system Net Sales New products (Allergy) (Dry eye) (Glaucoma) (JPY billions) Existing products Improve diagnosis and compliance rate by deploying treatment support tools • Glaucoma treatment compliance package ("ACT Pack") FY2020 FY2025 • Dry eye diagnostic support system Contribution +2%pt profit ratio: 41% (vs. FY2020) Alesion: Trademark of alliance partner Nippon Boehringer Ingelheim *1 FY2025 plan figures compared to FY2020 Copyright© 2021 Santen All rights reserved. 19
New Channel Development and Introduction of New Products A for Sustainable Growth in China In anticipation of continued reforms to the healthcare system, project total sales of JPY+17.0 B*1 through a shift in focus away from public Tier 3 hospitals to multi-channel sales and sales growth of new products leveraging digital technologies and academia Initiatives for stable growth/profit ratio improvement Concrete actions to achieve plan While factoring in VBP impact, achieve growth by 1 Channel development outside of developing new channels and introducing new products Tier 3 hospitals 1 2 • Develop/penetrate channels such as private New channels New products hospitals and retail, which are expected to expand – e.g. Collaborations with online pharmacies, Net Sales rebuilding of sales structure (JPY billions) 40.0 2 Expand sales of new products starting with 23.3 Diquas and Tapros FY2020 VBP FY2025 • Digitech use impact – Diversification of activities/expansion of coverage Contribution +1%pt • Strengthening scientific approach profit ratio: 42% (vs. FY2020) • Building a locally-optimized medical affairs capability *1: FY2025 plan figures compared to FY2020 Copyright© 2021 Santen All rights reserved. 20
A Business Development in Asia and EMEA Sales and profit ratios have grown steadily in Asia and EMEA over the past few years. Increased sales coupled with improved profitability through expansion of new product sales and optimization of operating expenses will be key over the next 5 years Asia EMEA CAGR CAGR +15% 35.0 +6% 50.0 37.0 37.9 Net Sales 16.5 17.2 (JPY billions) Finan- cial KPI FY2019 FY2020 FY2025 FY2019 FY2020 FY2025 Contribution +3%pt +3%pt 35% 40% 27% 30% profit ratio (vs. FY2020) (vs. FY2020) New product launches and maximization of sales • Both regions:STN2000100 (PRESERFLO MicroShunt), Ikervis/Verkazia • Asia: Diquas, Tapcom, Eybelis, STN1013900 (Rhopressa) Key measures • EMEA: Ducressa, Puralid, Cosopt PFMD/Taflotan PFMD, STN1013001 (Catioprost) in MTP2025 Operating efficiency improvement through utilization of digitech and thorough implementation of PDCA cycle Copyright© 2021 Santen All rights reserved. 21
B - 1 Establish Profitable Structure in Americas Steadily build a profitable framework for Rx business by leveraging Eyevance's business structure and launching late-stage development products Projected sales and profit (FY2020~FY2025) Concrete actions to achieve plan Strengthen Rx business platform based on Eyevance's business structure • Implement commercial strategy and invest resources CAGR • Form a development and sales alliance with Glaukos +64% for device business, while allowing Santen to focus its 10.0 Net Sales resources on Rx (JPY billions) 24.0 14.0 Leverage profitable structure while aiming for virtuous cycle to further boost R&D and 4.0 2.0 business development capabilities in US FY2020 FY2021 FY2025 New products (FY2025) Aim to establish Santen’s presence swiftly Contribution -- -- 54% in largest ophthalmic market profit ratio STN2000100 not included in the net sales figures as it is under consideration. Copyright© 2021 Santen All rights reserved. 22
B - 2 New Disease/Others (Example): Ptosis Currently developing the first eye-drop medical solution for ptosis patients with the aim to enter an area where unmet needs are significant. Will also expand the business by developing sales channels in non-ophthalmology fields Direction / progress for business launch Market • Patients: 260 million (Diagnosed, but no definitive treatment available other than surgery; strong need for eye-drop medical solution) Potential*1 • Consumers: 870 million (Significant needs for eyelid lift-ups among undiagnosed people) • Developing the first eye-drop medical solution for ptosis patients. Launch from Asia after FY2023 • Osmotica has already obtained approval in US under brand name UPNEEQ™(Jul. 2020) R&D • Asia: Preparing for application using approved data in US • Japan: Aiming to commence clinical trials in FY2021 *2 • EMEA/China: Aiming to flesh out development plan • Pursue sales leveraging existing commercial platform for Sales ophthalmic area channels • Promote development of sales channels in non-ophthalmic fields: consider leveraging digitech for customer engagement *1 Estimated by Santen based on UPNEEQ Target Patient and Consumer Survey 2021(n= Approx. 400 × 10 countries: Japan/China/South Korea/Thailand/the Philippines/ five European countries) and various academic articles on number of patients, etc. *2 Source for description/picture: UPNEEQ website (https://ecp.upneeq.com/ ) and brochure Copyright© 2021 Santen All rights reserved. 23
C Strengthening Foundation as a Global Company Strategic direction Policy Structure to promote thorough lifecycle management Strengthen product Development structure: particularly in US and China 1 development • Global project management scheme: Enhance rigorousness of capabilities investment decision and progress management process Plant investment for business growth and cost reduction (Suzhou/China and Shiga/Japan) Strengthen product • Promote growth in China through Suzhou New Plant which is one of 2 supply infrastructure the world's largest plants • Reduce environmental impact (reduce CO2 emission, improve water/electricity consumption efficiency etc.) Reflection in Design KPIs and operational processes suitable for company-wide global management 3 financial KPIs and • Management indicators, strategy/monitoring processes etc. • Linkage between company-wide financial KPIs and business/functional business KPIs behavioral KPIs Establish Introduction of next-gen ERP and global implementation, 4 global platform dramatic efficiency improvements for mission-critical tasks Copyright© 2021 Santen All rights reserved. 24
C - 1 Strengthening Product Development Capabilities Santen’s development strengths Points to be strengthened in MTP2025 • Strength as ophthalmology specialty company Thorough life cycle management – Focus on disease needs – Explore / repurpose applications for Immediate regional expansion, product improvement, indication expansion, LoE countermeasures ophthalmic area • e.g. Alesion: Successful sales increase of Alesion LX – Strong linkage with clinical practice and development of new formulations Overseas development capability • Global capability Fundamental enhancement of clinical development • Strengthen development capability capability especially in US and China – Reaffirmed necessity to strengthen • e.g. Building capability for global expansion of Verkazia expertise and development capability around foreign medical affairs / device Global project management scheme • Enhance rigorousness of investment decision and Points to be improved / strengthened progress management process Alesion Trademark of alliance partner Nippon Boehringer Ingelheim Copyright© 2021 Santen All rights reserved. 25
1. Santen's Vision & Mid-/Long-term Targets (KPI) 2. Business Plan & Strategy/Initiatives 3. Long-term Direction for Further Future Growth Agenda 4. Shareholder Return Policy 5. ESG Strategy/Initiatives 6. Details of Business Strategy Copyright© 2021 Santen All rights reserved. 26
Three Ways to Capture Growth Potential Ophthalmology Santen Innovation 2030 Strategy Ecosystem Wellness Three ways to 1 Disease 2 Region 3 Channel capture growth Achieve new growth in Accurately understand Aggressively develop a potential four disease areas, not regional needs and hybrid online-offline model just extrapolating on the (1) address growth to respond to the existing business potential in China/Asia expansion of out-of-pocket • Glaucoma, (2) provide advanced channels and private myopia, ptosis, medical care in health insurance retinitis pigmentosa developed countries Copyright© 2021 Santen All rights reserved. 27
1 Significant Growth Potential Capture new growth in four disease areas, not just extrapolating on existing areas Retinitis pigmentosa Position as area of new growth potential and promote commercialization Myopia Ptosis Continue to pursue further growth and expansion as key disease area Glaucoma 2020 2025 2030 Copyright© 2021 Santen All rights reserved. 28
1 Extensive Pipeline to Drive Growth Holistic coverage of ophthalmic area including diseases with limited treatment options # of patients*1 Pipeline Disease area (global) (Examples) Launch target Projected sales (FY2030) Retinitis Approx. STN6000100 (jCell) FY2026~ pigmentosa 1.5 million Approx. STN1012700 New Myopia STN1013300 FY2025~ +JPY 300.0 billion*2 2.0 billion STN1013400 • Abundant pipeline will drive growth through Ptosis+ Approx. STN1013800 FY2023~ FY2030 Eyelid worries 0.6+ billion STN1011700 Approx. STN1012600 Core Glaucoma STN1013900 FY2021~ 95 million STN2000100 *1 RP) Santen internal estimates, Myopia) Holden, et al, 2016 Ophthalmology, Ptosis+Eyelid worries) Santen internal estimates, Glaucoma) World report on Vision *2 Increase potential from FY2025 level. This is a best-case scenario which does not factor in development risk. This includes potential business development projects Copyright© 2021 Santen All rights reserved. 29
2 Unmet Needs in Each Region and Santen's Direction Accurately understand regional needs and (1) address growth potential in China/Asia (2) provide medical care with new modality in developed countries Unmet needs Santen's direction Expansion of Uncover potential markets ophthalmology medical • Create new markets from scratch to meet needs by providing infrastructure medical infrastructure China • Lack of / under- • Examples of recent initiatives: & – Support for improving productivity of medical staff (expand development of Asia quality and quantity) healthcare practitioners, – Support establishment of medical infrastructure screening facilities, insurance – Strengthen cooperation with related organizations such as system, etc. to meet academic societies and ITU*¹ rapidly increasing needs – Establish dedicated department internally Response to refractory Focus on new modality (e.g. STN6000100(jCell)) diseases with limited • Establish center of excellence, support for doctor education, Developed treatment options medical examination cooperation support countries • Example pf recent initiatives: Establish / strengthen dedicated • e.g. Retinitis pigmentosa team in EMEA *1:International Telecommunication Union Copyright© 2021 Santen All rights reserved. 30
2 Optimization of Ophthalmology Ecosystem in China/Asia Develop/optimize ophthalmology ecosystem together with partners, to uncover market potential, and drive business growth. Concrete measures already being implemented in China and Asia Targeted ecosystem (China example) Santen's business growth Improve awareness of ophthalmic diseases Health care • Disease awareness & screening payer Data center • Use digitech to reach out to patients General – e.g. Tie-up with myopia app hospital Shared Referral Rx/2B Online/ Medicinedelivery Expand quantitative/qualitative treatment offline delivery/ visit disease capacity & enhance treatment compliance mgmt. Patient • Support training of healthcare providers Primary Pharmacy • Diagnostic support using digitech hospital • Provision of medical information Shared Rx/ 2B delivery Patient flow Santen's Product flow business Pharmaceutical co./other Cash flow growth healthcare providers Copyright© 2021 Santen All rights reserved. 31
3 Channel Changes and Santen's Direction To respond to expansion of out-of-pocket channels & private health insurance, aggressively develop a hybrid online/offline model to leverage Santen's strength in ophthalmic coverage Channel changes: Santen's direction: Expansion of out-of- Deploy a hybrid online/offline model that leverages Santen's pocket channels & coverage of ophthalmologists private health insurance*1 • Example of recent initiatives: e.g. In principle, dry eye Collaboration with online pharmacies has already started in China is not covered by public insurance in China*2 Image for hybrid model based on patient flow Disease Examination and Follow up with patients Online enlightenment/ Offline prescription by Online to ensure drug screening & guiding ophthalmologists purchase and patients to medical treatment compliance institutions Santen's existing strength (ophthalmologist coverage) *1 Includes both narrowly defined private and corporate insurance, *2 Dry eye is already not covered by insurance except post cataract surgery. Therefore patients are required to pay based on prescriptions issued by medical institutions (Coverage by private health insurance differs according to insurance package) Copyright© 2021 Santen All rights reserved. 32
1. Santen's Vision & Mid-/Long-term Targets (KPI) 2. Business Plan & Strategy/Initiatives 3. Long-term Direction for Further Future Growth Agenda 4. Shareholder Return Policy 5. ESG Strategy/Initiatives 6. Details of Business Strategy Copyright© 2021 Santen All rights reserved. 33
Shareholder Returns Policy We enforce the sustainable shareholder returns and BD investment to increase shareholder value. Shareholder return: 1/3 or more of Utilize operating CF to enhance operating cash flow shareholder value Optimize Dividend payout ratio of 40% or more • Secure a dividend payout ratio of at least balance + flexible share buybacks 40% between future • Apply financial discipline to carefully select growth and BD investment: tens of billion JPY~ and implement strategic investments that shareholder Strategic investment for mid-/long-term growth will drive mid-to-long term growth and return • Enhance Rx pipeline where strengths can be increase corporate value leveraged • Flexibly return surplus funds through share • New business areas buybacks Capital investment: 100.0B JPY Enhancement Investment to maximize existing business Utilize debt given solid prospects for of core • Capex for new facilities in Japan/China recovery of investment business • Improvement of productivity through the implementation of next-generation ERP etc. Maintain necessary cash for business continuity Maintain current level (Secure working capital) Copyright© 2021 Santen All rights reserved. 34
1. Santen's Vision & Mid-/Long-term Targets (KPI) 2. Business Plan & Strategy/Initiatives 3. Long-term Direction for Further Future Growth Agenda 4. Shareholder Return Policy 5. ESG Strategy/Initiatives 6. Details of Business Strategy Copyright© 2021 Santen All rights reserved. 35
Four ESG Materialities Based on Sustainability Policy Aim to achieve continuous growth by focusing on four materialities and contributing to ongoing social innovation under our corporate vision 1 Development and stable supply of socially significant products and services (Happiness with Vision) Enrichment of products, information, and services along the three pillars of Ophthalmology, Wellness, and Inclusion Enhancement of responsible supply chain, safety monitoring, and customer service • Aiming to reach over 60 million patients*1 2 3 4 Nurturing a corporate Contribute to the Global environment culture promoting strengthening of governance protection value creation and achieving social fairness and equity Countermeasures against climate change, reduction of environmental DE&I*2 - Promote diversity with a Management effectiveness, diversity, impact focus on gender, nationality, and the compliance and respect for human • Scopes 1 & 2: CO2 emissions visually impaired rights aimed at ensuring medium FY2025: 25% reduction, and long-term growth FY2030: 50% reduction • Shift to bioplastic eye-drop containers FY2030: 60% *1 Estimated total no. of patients to which Santen contributed (disease areas: inflammation/allergies, cornea, glaucoma, cataracts) in FY2019 was approx. 43 million, calculated based on JMDC's estimated total no. of patients for Santen’s Rx products and Santen’s shipment data *2 Diversity, Equity & Inclusion Copyright© 2021 Santen All rights reserved. 36
Diversity, Equity & Inclusion (DE&I) Initiatives Further strengthen diversity initiatives through global collaboration with partners Global advocacy for people with disabilities Santen's commitment to through “The Valuable 500” initiatives gender equality and women’s empowerment Santen's unique support, employment, and job development for people with visual impairment Healthy gender balance at through activities, including Board and senior Blind Football*1 management levels *1 Santen has signed a 10-year partnership agreement with the Japan Blind Football Association (JBFA) through 2030 in an effort to popularize blind soccer Copyright© 2021 Santen All rights reserved. 37
1. Santen's Vision & Mid-/Long-term Targets (KPI) 2. Business Plan & Strategy/Initiatives 3. Long-term Direction for Further Future Growth Agenda 4. Shareholder Return Policy 5. ESG Strategy/Initiatives 6. Details of Business Strategy Copyright© 2021 Santen All rights reserved. 38
Japan Business Takeshi Ito Director of the Board, Executive Corporate Officer, Head of Japan Business, Head of Japan Sales & Marketing Division Copyright© 2021 Santen All rights reserved. 39
Pipeline Under the Medium-term Plan We plan to rollout an extensive range of new products/formulations and solutions which will drive growth in key disease areas New products/formulations (launch target) Solutions • (FY2019): Alesion LX Kayumi Dasu app Allergy • (FY2024): Alesion new formulation (already available) (FY2022) • (FY2022): Diquas new formulation Dry eye • (FY2023): STN1013500 Dry eye diagnostic support system • (FY2021): Brimonidine GE • (FY2022): Eybelis PFUD, STN2000100 (PRESERFLO MicroShunt) ACT Pack Glaucoma • (FY2023): Tapros with new instillation system (already available) Tapcom with new instillation system • (FY2024): STN1013900 (Rhopressa) • (FY2025): STN1012600 (Sepetaprost) Alesion: Trademark of alliance partner, Nippon Boehringer Ingelheim Copyright© 2021 Santen All rights reserved. 40
Allergy Alesion New Formulation: Innovation in Treatment Concept Ensuring all-day comfort for patients with new formulation, driven by innovation in treatment concept Current medical What Santen wants to achieve challenges Ensure all-day comfort for patients Concept of proactive through new formulation through improvements to Alesion LX which treatment is a work-in- represents an advance in proactive treatment progress • Allergy treatment usually starts after symptoms appear Transformation 【Anti-allergy eye drop market share image】 • Eye drops are applied of allergy treatment concept after itching occurs; • From "anti-itch" use to "non-itch" use Others dosage regimen typically not followed As a result, "reshape" anti-allergy eye drop share New formulation • New formulation: POC*1 achieved Alesion Alesion LX FY2020 Future Alesion: Trademark of alliance partner, Nippon Boehringer Ingelheim *1 POC (Proof of Concept): to demonstrate the development concept. In development of a new drug, it means the efficacy/safety of the candidate is confirmed in humans. Copyright© 2021 Santen All rights reserved. 41
Dry eye Significance of Development of Diquas New Formulation Provide therapeutic effects while reducing the burden associated with frequent eye drop application What Santen wants to Current medical challenges achieve with new formulation Many patients don't achieve adequate therapeutic effects Longer effect than existing products as a consequence of not applying eye drops six times per day • Existing product administered six times a day • New formulation enables application three Doctors 【No. of application times for eye drops as instructed by Drs.】*1 times a day • Currently, many patients are 46 Providing therapeutic effects while not instructed to apply eye 28 reducing the burden associated with drops six times per day by 27 16 11 frequent eye drop application their doctor 3 7 3 1 2 3 4 5 6 7+ When Approval process is now well underway eyes • Plan to launch in FY2022 are dry 【Percentage of patients who don't apply eye drops as instructed】*1 Patients • Percentage of patients who Expect approx. 90% compliance with fail to comply increases as three-times-a-day application 67% the number of daily 40% 46% applications specified rises 31% • Approx. half fail to comply 11% when instructed to apply six 0% 0% times a day 1 2 3 4 5 6 7+ *1 Diquas internal survey Copyright© 2021 Santen All rights reserved. 42
Dry eye Development of Dry Eye Diagnostic Support System Maximize value of Diquas with a dry eye diagnostic support system What Santen wants to achieve Current medical challenges with dry eye diagnostic support system • Doctors: More accurate diagnosis requires more time and experience. Development of Also hard to explain results to patients in an easily visualized manner dry eye diagnostic support system • Patients: Find it hard to recognize their condition and improvements, making motivating patients to seek treatment a challenge. Having to apply • Developing a system to promote eye drops too frequently is troublesome implementation of TFOD/TFOT*2 in daily practice, and aid patient understanding and Dry eye Dry eye Dry eye diagnosis/ Diquas Continuation of compliance through visual explanations potential patients outpatients drug prescription prescription Diquas treatment Solutions are being developed to address factors common to all three declines Realization of a world in which both doctors 22.00 mil. and patients are highly motivated to ppl*1 undertake treatment 11.80 mil. ppl*1 8.65 mil. ppl*1 2.40 mil. ppl*1 1.19 mil. ppl*1 As a result, (Challenge) (Challenge) (Challenge) (Challenge) • Maximize Diquas usage opportunities Patients don't Low staining No tear fluid Discontinue due rate if dry eye treatment is to side effects or • Maximize satisfaction of doctors/ visit hospital is not suspected given for dry eye hassle of having to patients visit hospital *1 Santen internal estimates, *2 TFOD (Tear Film Oriented Diagnosis): Stratified diagnosis of ocular surface, TFOT (Tear Film Oriented Therapy): Stratified therapy of ocular surface Copyright© 2021 Santen All rights reserved. 43
Glaucoma Products / Solutions Provided by Santen Provide treatment packages through an extensive range of products / solutions New : Pipeline scheduled for launch during MTP2025 Mild Moderate Severe (Eybelis) Products Formulation Mono Therapies New Tapros with new instillation system, Eybelis, New STN1013900, New STN1012600 Combination Therapies (Formulation with New Tapcom with new instillation system, Cosopt, STN1014000 new instillation system) Device MIGS (Micro invasive glaucoma surgery) New STN2000100(PRESERFLO MicroShunt) Solutions Glaucoma treatment compliance package ACT Pack Copyright© 2021 Santen All rights reserved. 44
Glaucoma Rollout of New Instillation System and Eybelis Further contribute to glaucoma treatment by launching a new instillation system and Eybelis during MTP2025 エイベリス New instillation system Eybelis Explanation of drug Current medical challenges Current medical challenges selection provided by Fail to apply • Approx. 45% of patients 29% (can't look up) Patient participation in drug selection doctor can't apply eye drops increases their motivation and satisfaction Patient is also 17% Fail to apply with treatment involved in explanation properly (can look up) • Q1. Which explanation do patients of drug selection prefer? 26% 29% 29% 50% Apply successfully • Q2. Which explanation would lead to patients continuing to apply eye *1 drops? • Q3. Which explanation would lead to 74% 71% 71% continued outpatient treatment? Added value created by Santen Help all patients, including the elderly, If Eybelis is added as an option, we to properly apply eye drops anticipate more patients will choose it Q1 Q2 Q3 (n=108) *2 (prevents misapplication of eye drops) • No need to look up or raise your arm when applying eye drops, enabling Added value created by Santen proper eye drop application Support patient motivation and satisfaction by encouraging patient participation in drug selection with Eybelis *1 K. Namiguchi et.al., Atarashii Ganka (2017), J. L. Stone et.al. Arch Ophthalmol. (2009), G. Hosoda et.al. Atarashii Ganka (1993), Santen internal surveys *2 E Miyamoto et.al, Medicine & Pharmacology 78(3)1-6, 2021 Copyright© 2021 Santen All rights reserved. 45
Glaucoma New Instillation System and Eybelis as New Standard Realize a world in which patients' potential needs are recognized by the patients themselves, physicians provide treatment to satisfy those needs, and patients can commit to treatment with a sense of satisfaction Reshaping of market with Tapros with new instillation system and Eybelis. 1 (PG single agent market share) Provide new instillation system for patients who can't apply eye drops properly 2 Satisfy patients' needs with Eybelis 1 Patients • Patient participation in drug selection increases 3 their motivation and satisfaction with treatment who can't apply eyedrops Eybelis 2 3 properly 6% Increase no. of treated patients through Tapros with new glaucoma treatment compliance package 19% instillation system (ACT Pack) FY2020* Future *Note: Bimatoprost is not included in PG single agent market Source: Copyright © 2021 IQVIA. JPM 2020.4-2021.3, Santen analysis based on IQVIA data. Reprinted with permission. Copyright© 2021 Santen All rights reserved. 46
Propose New Treatment Standard to Patients / Healthcare Professionals Make a much greater contribution to treatment by proposing new, more patient-oriented treatments and practices to healthcare professionals Realization of corporate Decrease in blindness rate Wins for philosophy patients Contribution to treatment Improved QOV*1 with Santen drugs Increased sales Wins for healthcare Wins for professionals Santen Contribution to community Increased patient satisfaction Stable clinic management *1 Quality of Vision Copyright© 2021 Santen All rights reserved. 47
China Business Takayuki Yamada Corporate Officer, Head of China Business Copyright© 2021 Santen All rights reserved. 48
China: New Channels and New Products for Sustainable Growth Given ongoing reform of the healthcare system, we aim to achieve sustainable growth in China by shifting our focus from Tier 3 hospitals to multi-channel sales, and expanding sales of new products leveraging digitech and scientific approach Efforts to achieve plan Expand sales by developing and penetrating channels such as private Channel hospitals and retail, which are expected to expand going forward as a development result of healthcare system reforms outside of • Cooperation with online pharmacies Tier 3 hospitals • Rebuilding of sales structure Expand sales of new products starting with Diquas and Tapros New product • Diversification of activities and expansion of coverage using digitech sales expansion • Strengthening of scientific approach • Steady building of a locally-optimized medical affairs capability Cooperation with Contribute to establishment/development of ophthalmology local partners ecosystem in China in alliance with local partners Copyright© 2021 Santen All rights reserved. 49
Details of Initiatives 1: Marketing Activities in China Enlightenment and marketing activities to Net sales by channels expand channels Shift sales resources away from large public hospitals to expand Steadily conducting enlightenment and marketing channels, aiming to achieve stable sales expansion activities through explanatory meeting, training, etc. (JPY billions) 40.0 Large public hospitals 27.0 22.3 23.3 21.4 12.5 12.1 (46%) 13.2 12.8 (57%) (52%) (62%) Non-public hospitals / retails etc. 14.5 9.5 11.2 8.2 (54%) (43%) (48%) (38%) Key sales • Regional marketing training: 30 times activities • Medical institution meetings, scientific FY2018 FY2019 FY2020 FY2021 FY2025 meetings: 200 times (Jan 2021~) (fcst) (fcst) – Already covered 2,000 HCPs and 2,000 pharmacists, etc. Copyright© 2021 Santen All rights reserved. 50
Details of Initiatives 2:New Product Development/Sales in China Development/sales status Market share*1 Projected target population in China*2 Diquas • Launched in FY2018 0.1% (Feb. 2020) • Approx. 16 million ppl • Actual sales of approx. →1.6% (Feb. 2021) • No. of patients is on the rise due JPY0.7 billion (FY2020) to increased computer work, • FY2020 actual: +329% (YoY) widespread use of contact lenses FY2021 forecast: +288% (YoY) etc. • Net sales growing especially in • Dry eye potential patients are private hospitals/retail channels estimated to be approx. 96 million ppl including untreated population*3 Tapros • Launched in FY2015 Achieved top share (33.1%) in • Approx. 0.9 million ppl • Listed on NRDL (National prostaglandin single agent market • No. of patients is also increasing Reimbursement Drug List) as of Feb 2021 in China due to aging society • Actual sales of approx. • Established position as first-line • Total prevalence is estimated to JPY0.6 billion (FY2020) brand for new glaucoma patients be approx. 20 million ppl • FY2020 actual: +52% (YoY) FY2021 forecast: +363% (YoY) *1 Volume base/Source: IQVIA, *2 Source: DRG, *3 based on diagnosed population as of 2020 2020/Decision Resources, LLC. All right reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. Copyright© 2021 Santen All rights reserved. 51
Initiatives for Long-term Growth 1: Development, Manufacturing, Sales Structure To achieve medium- to long-term growth, establish an integrated system for development, manufacturing, and sales in China, and promote development, manufacturing, and sales that are rooted in the local community Establishment of local development capability • Dramatically strengthen local clinical development capability in preparation for new product Development development/launches in long term • Pipeline examples; STN1012700 (Atropine) STN1013400 (AFDX) STN1007603 (Verkazia) STN2000100 (PRESERFLO MicroShunt) Establishment of sales Sales Manufacturing Construction of Suzhou capability new plant • Expand coverage using digitech • Undertake cost reduction • Strengthen scientific approaches and respond to future based on data and science demand expansion Copyright© 2021 Santen All rights reserved. 52
Initiatives for Long-term Growth 2: Construction of New Plant in Suzhou Promote business growth in China by meeting the ever-increasing demand for products, and strengthening future global product supply structure • Competitive advantage – Even as of FY2021, Suzhou Plant is the only plant operated by a pharmaceutical company specializing in ophthalmology to obtain EU-GMP in China, and is unparalleled in its high level of technological capabilities, quality and production capacity (finished products) – Further strengthen our competitive advantage through construction of Suzhou new plant as one of the world's largest eye drop factories equipped with the latest equipment • Start of operations – 2025 (Gradual ramp-up) • Cost improvement initiatives – Automation/manpower saving, etc. • Environmental considerations – CO2 emission reduction – Improvement of water and electricity consumption efficiency *Image of completed building *As of Apr. 2021 Copyright© 2021 Santen All rights reserved. 53
Global R&D Peter Sallstig Corporate Officer, Head of Product Development Division Copyright© 2021 Santen All rights reserved. 54
Focus Areas of Global R&D Toward MTP2025 and Beyond New growth opportunities 2 Retinitis • Pursuing scientific innovation for ophthalmic diseases with high pigmentosa etc. Unmet Medical Needs as a specialized company in ophthalmology New growth opportunities 1 Ptosis, Myopia • Solve unmet patient needs and eye problems leveraging the ophthalmic product development and etc. production capacity cultivated through Rx/OTC development Develop products based on Glaucoma • Area of highest focus in Global R&D real market needs Core business area Dry-Eye toward MTP2025 and beyond Allergy • Keep expanding contribution to patients based on our capabilities etc. and presence in existing market Copyright© 2021 Santen All rights reserved. 55
Expected Pipelines by / After MTP2025 Potential New Global product Under review STN1013900 STN1014000 Value expansion of product based on real market needs Gla: Asia Launch prior to JP Gla: Asia expected Launch Target FY2021 FY2022 FY2023 FY2024 FY2025 FY2026 and beyond PRESERFLO Verkazia Eybelis, PFUD Tapros with new insti- STN1010900 STN1012600 STN1010905 MicroShunt VKC: US Gla: JP llation system, Gla: JP Uveitis: US Gla: JP, US, EMEA MGD Gla: CN Core Business Brimonidine GE Eybelis Tapcom with new insti- STN1013900 Tapcom Gla: JP, Asia Gla: US llation system, Gla: JP Gla: JP Gla: CN Glaucoma PRESERFLO Verkazia Ikervis, PFMD Alesion NF* Catioprost MicroShunt New bottle Next-gen. eye- drop Dry-Eye Gla: Asia VKC: CN Dry eye: Asia Allergy: JP Gla: Asia development applicator Allergy Diquas NF* STN1013500 Eybellis, PFUD New formulation Dry eye: JP Dry eye: JP Gla: CN, Asia Drug delivery system etc. development Cationorm Catioprost Dry eye: CN Gla: EMEA Promoting platform-technology development to PRESERFLO enhance product life cycle management MicroShunt *NF: new formulation Gla: JP Ptosis, Myopia, STN1013800 STN1012700 STN1012700 STN1013300 STN1013400 Opportunity New Growth Ptosis: Asia, EMEA Myopia: JP Myopia: CN, Asia Myopia Myopia Presbyopia STN1013800 STN1013600 etc. Ptosis: CN, JP Presbyopia STN6000100(jCell) LCM of jCell Retinitis Pigmentosa etc. RP:EMEA, JP, CN (Incl. other than RP) This is not an exhaustive list of all the pipeline items through 2030. The list is limited to items with disclosure agreements with partner companies. Schedules are based on the assumed best possible case as of May 19, 2021 Copyright© 2021 Santen All rights reserved. 56
Mechanism to Drive Value Creation for Patients External innovations Development engine Global launches & deep dive into market needs Ophthalmology Innovation Global Product Development Division Center Leader: Peter Sallstig Academic innovations: Reza Haque SERI, UCL etc.*1 Japan Global Clinical Dev. & Operations Business Development Orchestrate global development: Uday Arulmani Pipeline asset partnership and/or M&A: Ken Araki China EMEA China Product Development Twenty Twenty Therapeutics Strengthen China development capability: Digital tech-enabled solutions for Kenji Morishima vision care US Asia CVC (Santen Venture) Pharmaceutics and Pharmacology Investing in assets and targets in line Enhance LCM to maximize value of product: with Corporate strategy Kazuhito Yamada Discover external innovation Achieve new value creation and robust Understanding real needs leveraging “Santen’s Eye” based on global product development based on through touchpoints with deep understanding of real established core functions led by doctors & patients after voice/needs of doctors and patients experienced leadership product launches *1 SERI: Singapore Eye Research Institute, UCL: University College London, academic collaboration partners Copyright© 2021 Santen All rights reserved. 57
Santen Global R&D: Strong Leadership Global Product Development Division Peter Sallstig Kenji Morishima Uday Arulmani Kazuhito Yamada Flavio Lima Franz Buchholzer Head, Head of China Product Vice President, Head of Pharmaceutics and Vice President, Vice President, Representative, US R&D, Development, Global Clinical Development Pharmacology Department, Global Medical Affairs Global Regulatory Affairs Corporate Officer Representative, Asia R&D, &Operations Representative, Japan R&D Corporate Officer Ophthalmology Innovation Center Reza Haque Takeo Hirose Almira Chabi Abu Abraham Hisao Shimada Sreenivasu Mudumba Najam Sharif Head Representative Head Vice President, Vice President, General Manager, Vice President, Vice President, Glaucoma and Vitreous and Retina, Ocular Surface and Therapeutic Modality Global Alliance and Neuroprotection, Therapeutic Area Strategy Anterior Segment, Innovation External Research Therapeutic Area Strategy Therapeutic Area Strategy Copyright© 2021 Santen All rights reserved. 58
Happiness with Vision 59
Appendix Copyright© 2021 Santen All rights reserved. 60
Looking Back at MTP2020 (1/2): Qualitative Perspective Have developed what will be the core strengths of MTP2025, but need to continue to work on execution issues Goals Achievement • To become a “Specialized • While global presence has been enhanced by expanding sales channels, Pharmaceutical Company with a Global Fundamental need to strengthen quality in the future Presence” policy • Seeds sown for growth drivers (proactive business development) . • Construct a path for sustainable growth Promoted management efficiency. Continue to address execution issues beyond FY2020 Existing markets: Leveraged experience in Japan & EMEA to achieve above- 1. Grow faster than the market through market growth in China & Asia progress in global business strategy New markets: Built foundation in US through acquisition of Eyevance Achieved a certain level of results in value maximization and enriching the pipeline 2. Enhance the product pipeline and Promoted initiatives to meet a variety of unmet needs Strategic develop new treatment options Deployment of eye drop bottle & support device, cell therapy, etc. goals Recognize issues with development system, such as delays in global development Launched multiple initiatives to improve efficiency 3. Raise strength / efficiency of business • Construct new building in Shiga and new plant in Suzhou framework; boost human resource and • Introduce next-generation ERP organizational capabilities • Transform into a global organization through introduction of management framework Copyright© 2021 Santen All rights reserved. 61
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